FDA Adverse Event
Death
Summary report: N
ONE STEP COMPLETE ELECTRODE, 8 PER CASE
MDR report key: 2993017
·
Received February 28, 2013
Report
- Report Number
- 1220908-2013-00453
- Event Type
- Death
- Date Received
- February 28, 2013
- Date of Event
- January 15, 2013
- Report Date
- February 7, 2013
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MLN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORP HAS NOT RECEIVED THE PRODUCT FOR EVAL AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE TREATING A (B)(6), MALE PT, THE ELECTRODES WERE PLACED ONTO THE PT, WHILE PERFORMING CPR, THE CPR PUCK TORE THE PT SKIN. CPR WAS PERFORMED FOR APPROX ONE HOUR AND FORTY-FIVE MINUTES. THE CPR PUCK WAS REMOVED TO CONTINUE CPR. COMPLAINANT INDICATED THAT THE PT SUBSEQUENTLY EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 86742 | ONE STEP COMPLETE ELECTRODE, 8 PER CASE | ELECTRODE | MLN | ZOLL MEDICAL CORPORATION | 8900-0214 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Death |